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510(k) Data Aggregation
K Number
K070987Device Name
SENTINEL LITHIUM ASSAY
Manufacturer
SENTINEL CH SPA
Date Cleared
2007-08-02
(118 days)
Product Code
NDW
Regulation Number
862.3560Why did this record match?
Applicant Name (Manufacturer) :
SENTINEL CH SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A lithium test system is a device intended to measure lithium levels in serum or plasma. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). For use on Architect and Aeroset analyzers.
Device Description
The Multigent Lithium test is a spectrophotometric method, which can be readily adapted to automated clinical chemistry analyzers. Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change of absorbance, which is directly proportional to the concentration of lithium in the sample.
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